BEUDAMED
    28 results · 14ms · Sources: EU EUDAMED, US FDA

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    Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable) 2087640-001-S FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG, SERVICE (gray, autoclavable) 2096513-001-S FLOW SENSOR ASSEMBLY 5697309 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF BCG 5697310 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·October 6, 2021

    McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

    FDA Enforcement
    Class II ·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·April 15, 2020

    The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a polyester support. For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromocresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample. Model/Catalog Number: 6844293

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·August 28, 2024

    MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems China Co., Ltd.·June 10, 2026

    LIFEPAK 35 ECG cable REF 11111-000041

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·February 12, 2025

    Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No

    FDA Enforcement
    Class II ·Ongoing·Edan Diagnostics·January 28, 2026

    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)

    FDA Enforcement
    Class II ·Ongoing·Withings·March 29, 2023

    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.

    FDA Enforcement
    Class I ·Ongoing·Braemar Manufacturing, LLC·January 1, 2025

    Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·October 4, 2023

    Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system

    FDA Enforcement
    Class II ·Ongoing·iRhythm Technologies, Inc.·November 16, 2022

    LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·September 10, 2025

    Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Ltd.·December 25, 2024

    Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Enforcement
    Class II ·Ongoing·Arrow International Inc·July 21, 2021

    ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by: Unconsciousness Absence of breathing, and Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients.

    FDA Enforcement
    Class II ·Ongoing·ZOLL Medical Corporation·July 10, 2019

    Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Enforcement
    Class II ·Ongoing·Arrow International Inc·July 21, 2021

    Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Enforcement
    Class II ·Ongoing·Arrow International Inc·July 21, 2021

    Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden cardiac arrest (SCA.)

    FDA Enforcement
    Class II ·Ongoing·Defibtech, LLC·December 4, 2024

    Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)

    FDA Enforcement
    Class II ·Ongoing·Defibtech, LLC·December 4, 2024

    Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Enforcement
    Class II ·Ongoing·Arrow International Inc·July 21, 2021

    Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,

    FDA Enforcement
    Class II ·Ongoing·Draeger Medical Systems, Inc.·May 3, 2023